NCT05164094Active, not recruitingPhase 1/2
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \<18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 867 (actual)
- First submitted
- 1 Dec 2021
- Start date
- 28 Dec 2021
- Primary completion date
- 5 Oct 2026
- Lead sponsor
- ModernaTX, Inc.
- NCT number
- NCT05164094
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 867
- From 28 Dec 2021 to the primary completion date, 5 Oct 2026
- 65 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had significant exposure to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to the screening visit, if the participant has not been fully vaccinated against COVID-19 at least 14 days prior to the screening visit.
- Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection.
- Note: Other inclusion and exclusion criteria may apply.
Other illness
- Has symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator).
- Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement.
- Has a history of myocarditis, and/or pericarditis.
Who the study is looking for
- According to the assessment of the investigator, is in good general health and can comply with study procedures.
- Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0).
- Part B:
- Healthy baseline EBV-seronegative adolescents from 12 to \<18 years of age at the time of consent (Screening Visit, Day 0).
- Part C:
- Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).
Age in the registry: 10 years to 30 years · Sex: All · Accepts healthy volunteers
Sites (65)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Smart Cures Clinical Research Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Benchmark Research - Austin - PPDS Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Tekton Research - Texas - Platinum - PPDS Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Velocity Clinical Research - Binghamton Coordinator of this site? Confirm its status | Binghamton | United States | Unknown status |
| ACRC Trials - Hunt - PPDS Coordinator of this site? Confirm its status | Carrollton | United States | Unknown status |
| Velocity Clinical Research - Austin - PPDS Coordinator of this site? Confirm its status | Cedar Park | United States | Unknown status |
| Coastal Pediatric Associates Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Charlottesville Medical Research Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Olivo Medical and Wellness Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Velocity Clinical Research - Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Benchmark Research - Colton - HyperCore - PPDS Coordinator of this site? Confirm its status | Colton | United States | Unknown status |
| Cedar Health Research - Fort Worth - PPDS Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | East Syracuse | United States | Unknown status |
| Alliance for Multispecialty Research, LLC - El Dorado - PPDS Coordinator of this site? Confirm its status | El Dorado | United States | Unknown status |
| Benchmark Research - Fort Worth - HyperCore - PPDS Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| ACRC Trials Coordinator of this site? Confirm its status | Frisco | United States | Unknown status |
| Velocity Clinical Research - Grand Island Coordinator of this site? Confirm its status | Grand Island | United States | Unknown status |
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| DM Clinical Research - Texas Center For Drug Development - ERN - PPDS Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Helios Clinical Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Medical Affiliated Research Institute Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| Jacksonville Center For Clinical Research - ERN - PPDS Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Velocity Clinical Research - Lafayette - PPDS Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Tanner Clinic Coordinator of this site? Confirm its status | Layton | United States | Unknown status |
| Johnson County Clin-Trials Coordinator of this site? Confirm its status | Lenexa | United States | Unknown status |
| Michael W Simon MD, PSC Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Velocity Clinical Research - Lincoln Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| Clinical Research Institute, Inc. Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Lucas Research Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Lucas Research Coordinator of this site? Confirm its status | New Bern | United States | Unknown status |
| Health Research of Hampton Roads Inc. - Newport News Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Velocity Clinical Research - Norfolk Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Coastal Carolina Research Center Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Lynn Health Science Institute Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Quality Clinical Research - ClinEdge - PPDS Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Velocity Clinical Research - Omaha Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Fomat Medical Research Coordinator of this site? Confirm its status | Oxnard | United States | Unknown status |
| Center For Clinical Trials LLC -Paramount Coordinator of this site? Confirm its status | Paramount | United States | Unknown status |
| ACRC Trials - Legacy Medical Village Headquarters Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Clinical Research Partners LLC - Richmond - ERN - PPDS Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| DM Clinical Research Coordinator of this site? Confirm its status | River Forest | United States | Unknown status |
| Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| Peninsula Research Associates - Headlands Research - PPDS Coordinator of this site? Confirm its status | Rolling Hills | United States | Unknown status |
| Velocity Clinical Research - Banning - PPDS Coordinator of this site? Confirm its status | San Bernardino | United States | Unknown status |
| California Research Foundation - 4180 Ruffin Rd Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Acclaim Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| iResearch Savannah - CenExel - PPDS Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Velocity Clinical Research - Savannah Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Velocity Clinical Research - Sioux City Coordinator of this site? Confirm its status | Sioux City | United States | Unknown status |
| Senders Pediatrics Coordinator of this site? Confirm its status | South Euclid | United States | Unknown status |
| Great Lakes Research Institute Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| DM Clinical Research Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| Sundance Clinical Research - ERN - PPDS Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Clinical Research Atlanta - Headlands - PPDS Coordinator of this site? Confirm its status | Stockbridge | United States | Unknown status |
| DM Clinical Research - Texas Center For Drug Development - ERN - PPDS Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| Orange County Research Center Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Valparaiso | United States | Unknown status |
| Velocity Clinical Research - Vestal Coordinator of this site? Confirm its status | Vestal | United States | Unknown status |
| Victoria Clinical Research Group Coordinator of this site? Confirm its status | Victoria | United States | Unknown status |
| Alliance for Multispecialty Research LLC, East Wichita Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.